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Right Ventricular Contractile Reserve in HF

Valutazione Ecocardiografica Della Riserva Contrattile Del Ventricolo Destro Dopo Carico Volemico Acuto Mediante Sollevamento Passivo Delle Gambe e Durante Infusione di Dobutamina in Pazienti Affetti da Scompenso Cardiaco a Frazione d'Eiezione Ridotta (HFrEF) e Preservata (HFpEF)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05797584
Acronym
RISE-HF
Enrollment
60
Registered
2023-04-04
Start date
2019-03-20
Completion date
2026-03-20
Last updated
2023-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

Right ventricle dysfunction and pulmonary hypertension are related to a worse prognosis in patients with heart failure with reduced left ventricular ejection fraction (HFrEF) or with normal left ventricular ejection fraction (HFpEF). There is preliminary evidence however, that the responses of the right ventricle and of the pulmonary hemodynamics to stress tests (especially physical stress) may allow to prognostically stratify these patients, as these responses may bring out latent right ventricle dysfunction or a normal contractile reserve in patients with dysfunction at rest. In view of the different pathophysiological mechanisms of the left ventricular dysfunction in HFpEF and in HFrEF, also the response and the adaptation of the righty ventricle to stress tests may be different in these two groups of patients. In this preliminary two groups of 20 patients with HFpEF and HFrEF will be subjected to to simple stress tests: passive leg raising and inotropic stimulus with dobutamine. This study intends to analyze, through colorDoppler echocardiography, the behaviour of the right ventricle and the pulmonary circulation during passive leg raining and infusion of dobutamine, in a cohort of patients with HFrEF or HFpEF. The analysis will be focused on the relation between echocardiographic parameters, especially those concerning right ventricular function and pulmonary hemodynamics, thereby comparing the responses observed in HFrEF vs HFpEF. Furthermore, correlations between the above-mentioned echocardiographic parameters and parameters of daily clinical practice will be assessed.

Interventions

DRUGDobutamine

Dobutamine 5.0 - 10.0 mcg/Kg/min ev

Passive leg raising for acute volume load

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* heart failure with reduced (EF ≤40%) or preserved (EF \> 50%) ejection fraction * echocardiographic acoustic window adequate for evaluation of outcome parameters * presence of tricuspid insufficiency which allows assessment of pulmonary artery systolic pressure

Exclusion criteria

* recent myocardial infraction (\<3 months) or unstable angina * moderate o severe aortic or mitralic valve disease * inadequate acoustic window * significant anemia (hemoglobin \<10 g/dl) * recent heart surgery (\< 3 months).

Design outcomes

Primary

MeasureTime frameDescription
Right ventricle (RV) volume - DobutamineBaseline and at 5 minutes after Dobutamine infusionChange in RV volume
Ejection fraction - DobutamineBaseline and at 5 minutes after Dobutamine infusionChange in ejection fraction
Right ventricle (RV) volume - Passive leg rainingBaseline and at 1 minute after passive leg raising for acute volume loadChange in RV volume
Ejection fraction - Passive leg rainingBaseline and at 1 minute after passive leg raising for acute volume loadChange in ejection fraction

Countries

Italy

Contacts

Primary ContactSergio Caravita, MD, PhD
s.caravita@auxologico.it+390261911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026